Senior Aseptic Process Validation Engineer, Cell Therapy

Biopharma Careers; Harvard (MA); On-site; USD 88,000 - 106,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) plan and protection

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer for the Devens Cell Therapy Facility. The role supports aseptic validation programs and leads risk assessments to ensure cGMP compliance in a cell therapy environment.

Ideal candidates have 2+ years in biopharmaceutical operations, experience with clean rooms, and strong communication skills, with responsibilities spanning documentation, regulatory readiness, and cross-functional collaboration.

Qualifications

• Experience in cGMPs and multinational biopharmaceutical regulations.
• Experience in aseptic processing/validation and clean room design.
• Experience with internal and health authority audits.
• Excellent verbal/written communication skills.

Responsibilities

• Support execution of APS/APV and aseptic performance qualifications.
• Author qualification/validation documents and ensure readiness for APS.
• Participate in aseptic risk assessments and summarize reports.
• Create product impact assessments for personnel and monitoring deviations.
• Lead site change controls and support regulatory inspections as SME.
• Collaborate across cross-functional teams and sites.

Skills

cGMP experience

Aseptic processing/validation

Audits experience

Strong communication

Education

Bachelor's degree in science/engineering/biochemistry

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer for the Devens Cell Therapy Facility. The role supports aseptic validation programs and leads risk assessments to ensure cGMP compliance in a cell therapy environment.

Ideal candidates have 2+ years in biopharmaceutical operations, experience with clean rooms, and strong communication skills, with responsibilities spanning documentation, regulatory readiness, and cross-functional collaboration.